Several national and state groups are working to help U.S. grain facilities comply with new rules for the handling, transportation and storage of food and animal feed that are part of the Food Safety Modernization Act.
The National Grain and Feed Association (NGFA) along with the Minnesota Grain and Feed Association (MGFA) and the Minnesota Department of Ag (MDA) recently hosted a series of regional seminars in Minnesota to educate industry members on the far-reaching new feed safety rules being promulgated by the Food and Drug Administration (FDA) to implement the Food Safety Modernization Act (FSMA).
The three, full-day seminars were part of NGFA's ongoing FSMA education and training efforts. The NGFA, in cooperation with state feed regulatory agencies and affiliated state and regional associations, has several more seminars scheduled in the coming weeks and will continue to add more seminars throughout the country.
NGFA Senior Vice President of Feed Services David Fairfield is leading these sessions with NGFA Feed Manufacturing and Technology Committee Chairman Matt Frederking, vice president of regulatory affairs and quality at Ralco Nutrition in Marshall, Minnesota.
Fairfield told the over 150 seminar attendees in St. Cloud, "feed is food" is the new paradigm. He said FSMA rules will apply to facilities required to register as a "food facility" with FDA under Bioterrorism Act requirements. Feed mills, grain elevators, grain processors that manufacture, pack process or hold food for humans or animals must register with the FDA. He added, "Farms (operations meeting FDA's definition of a 'farm') are exempt."
Under federal regulations, a farm is defined as "a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting." The definition continues to define what the "term farm" includes: https://goo.gl/….
Fairfield explained that, "The farm definition includes operations under one management devoted to the raising of animals that manufacture feed so long as the feed is consumed on that farm or another farm under the same management; e.g., feedlots, laying operations where hens are fed on farms under the same management." He noted that the "Current definition is size-neutral; FDA says this is a 'gap' they intend to address."
CGMP AND PREVENTATIVE CONTROLS FOR ANIMAL FOOD
"The FDA final rule current good manufacturing practice (CGMP) regulations and preventive controls for animal food is a complex rule," said Fairfield. "Facilities 'solely engaged' in storing grain and oilseeds are exempt from requirements to implement CGMPs and preventive controls; different treatment for elevators handling 'fruits' [i.e., lentils, kidney beans, pinto beans, lima beans, coffee beans, cocoa beans, peanuts, tree nuts and seeds for direct consumption (e.g., sunflower seeds)."
Elevators solely engaged in storing, handling such "fruits" are exempt from CGMP requirements, but not exempt from the preventive controls and supply chain program requirements. FDA, however, will issue special regulations if it is necessary to cover these excluded operations. Here is a link to the FSMA Final Rule for Preventive Controls for Animal Food: http://goo.gl/…
Preventive control rules are defined as those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of animal food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.
Frederking explained that, "Hazard means any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury in humans or animals. Known or reasonably foreseeable hazard means a biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the animal food."
Here are three reasons why grain elevators will need to comply with preventive control rules: aflatoxin, vomitoxin, fumonisin. The exemption for preventive control refers to facilities "that are solely engaged in the storage of unexposed packaged animal food that does not require time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens."
Here is a reminder of toxin levels unacceptable by the FDA in grain used for feed. "FDA policy prohibits blending different lots of grain to reduce the mycotoxin level in the resulting lot."
-- Aflatoxin (action levels): 20-300 ppb, depending on commodity and species to which fed;
-- Vomitoxin (advisory levels): 5-30 ppm, depending on commodity and species to which fed; 5-10 ppm in total ration;
-- Fumonisin (guidance levels): 5-100 ppm, depending commodity and species to which fed; 1-5 ppm in total ration.
INDUSTRY NERVOUSLY WAITS ON FINAL SANITARY TRANSPORTATION RULE
The Sanitary Transportation of Human and Animal Food proposed rule establishes requirements for vehicles and transportation equipment, transportation operations, training, and recordkeeping. For example, shippers would be required to inspect a vehicle for cleanliness or contamination prior to loading food that is not completely enclosed by its container. Operators of motor vehicles, railcars, and other equipment used in food transportation would be required to establish written procedures, subject to record keeping requirements, for cleaning their vehicles and transportation equipment, according to the FDA. At the meeting in St. Cloud, Fairfield said, "This rule will apply to feed mills and grain elevators and will impact our industry as well as truck and rail." The final rule was published April 1.
MGFA said: "The transportation rule, first proposed in January 2014, is the second-to-last regulation that needs to be finalized under the Food Safety Modernization Act. The proposed rule outlines food safety practices for shippers, receivers and carriers who haul food by truck, rail or ocean vessel." The final rule is expected to set requirements for equipment, sharing information, training and record-keeping in order to prevent contamination. "Pay attention," said Fairfield. Here is a link to the rule: http://goo.gl/….
Bob Zelenka, executive director of MGFA, told me, "MGFA meetings over the next year will obviously be heavily weighted towards the FSMA and, to date, the focus has clearly been on feed mills and not as much on grain elevator implications. That will certainly change going forward." Zelenka said that the Sanitary Transportation rule "will certainly affect grain elevators as much as and maybe more than it will affect feed mills."
I can only imagine how hard it would be to try and decipher the over 600 pages of the entire FSMA Act. Thankfully, with the seminars conducted by the NGFA and other state grain and feed organizations and state ag departments, there is relief in sight. Check with your local organization or https://www.ngfa.org to find out if there are training sessions offered in your state and/or to keep track of the latest information about the FSMA.
You can ask questions via the FDA "help line" as well. The FDA FSMA Technical Assistance Network (TAN) is now operational and providing technical assistance to industry, regulators, academia, consumers and others regarding FSMA implementation. http://goo.gl/…
Frederking told the crowd of over 150 attendees at the St. Cloud seminar, "We need to get over the fact that we think FSMA is going away; there are now dates in black-and-white that need to be complied with."
Here is a link to some key FSMA implementation dates: http://goo.gl/…
Mary Kennedy can be reached at firstname.lastname@example.org
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